MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48558528
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was stripped and the rod had to be cut in order to remove it.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the screw was examined and found to have a deformed hex head.Manufacturing files were reviewed and no anomalies were found.A functional test verified that a polyaxial screwdriver could be attached to the screw to make it monolithic with the screw.Conclusion: the probable root cause is not assuring the polyaxial screwdriver was firmly locked to the polyaxial screw as recommended in the stg.
Event or Problem Description
It was reported that the screw was stripped and the rod had to be cut in order to remove it.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5514622
• Report Number: 0009617544-2016-00123
• Device Sequence Number: 351995
• Product Code: KWP
• UDI-Device Identifier: 04546540596444
• UDI-Public: (01)04546540596444
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48558528
• Device Lot Number: 160095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR